Pursuant to its general rulemaking authority, N.J.S.A. 45:1-15.1, the New
Jersey State Board of Dentistry (the Board) is proposing new rules at
N.J.A.C. 13:30-8.1A, concerning the administration of deep sedation as it
relates to the practice that has come to be known as "sleep dentistry," and
N.J.A.C. 13:30-8.4, concerning the administration of enteral sedation with
single or multiple pharmacological agents. The Board is also proposing an
amendment to N.J.A.C. 13:30-5.1, which sets forth the general continuing
education requirements for dentists, in light of the new continuing education
requirements being proposed as part of new rule N.J.A.C. 13:30-8.4.

Proposed new rule N.J.A.C. 13:30-8.4 was originally proposed in the New
Jersey Register on November 3, 1997, at 29 N.J.R. 4641(a), as N.J.A.C.
13:30-8.3, with the heading "Conscious sedation with multiple oral agents."
During the public comment period on the original proposal, the Board received
several comments expressing concern about the proposed new rule. In light of
the comments received, the Board decided to defer adoption of the new rule.
Recently, the Board revisited the issue of conscious sedation and determined
that the concerns which formed the basis for the original proposal continue to
exist, and that rulemaking on this topic is necessary. Specifically, the Board
believes that the administration of pharmacological agents depresses the
central nervous system, creating a possible risk to patients, and that any
dentist who chooses to administer pharmacological agents must have a basic
knowledge of chemical sciences and be able to comport with the clinical
standard of care. Proposed new rule N.J.A.C. 13:30-8.4, although similar in
substance to N.J.A.C. 13:30-8.3, as it appeared in the original proposal in
1997, differs from the original proposal in several respects. The requirements
of proposed new rule N.J.A.C. 13:30-8.4 are explained below.

In response to the original proposal, the Board received comments from the
following:

COMMENT: Dr. Moss, on behalf of the New Jersey State Society of
Anesthesiologists, expressed concern that the proposal is limited to the
administration of multiple oral agents to achieve conscious sedation, when in
fact, the administration of a single oral agent can result in serious
consequences and even death. Dr. Moss recommends that the proposal be amended
to encompass conscious sedation with all oral agents. Dr. Cheifetz, on behalf
of the New Jersey Society of Oral and Maxillofacial Surgeons, also expressed
concern that the proposal does not go far enough to protect consumers because
administration of a single oral agent can cause untoward effects in a patient.

RESPONSE: The Board agrees with the concerns expressed by the commenters and
notes that new rule N.J.A.C. 13:30-8.4 establishes requirements for the use
of single and multiple oral agents when administered to achieve enteral
sedation of the patient.

COMMENT: Mr. Meisel, on behalf of the New Jersey Dental Association, objected
to the proposal as being unnecessary. Mr. Meisel observed that a majority of
the members of the Board's subcommittee that reviewed this issue expressed
their belief that the regulation was not necessary. Mr. Meisel further noted
that although the administration of multiple pharmacologic agents may create a
possible risk to patients, it does not follow that the risk is sufficiently
acute to require regulation. Many dental procedures entail risks, and for this
reason, persons who desire to practice dentistry in New Jersey must graduate
from an accredited dental school and pass a licensing examination. Additional
regulation in the area of pharmacologic administration is unnecessary. Mr.
Meisel observed that based on the limited number of "severe" adverse outcomes
resulting from the use of conscious sedation with multiple oral agents which
were presented to the Board in a letter by Dr. Paul Desjardins, it appears that
the overwhelming majority of licensed dentists utilizing multiple pharmacologic
agents to induce conscious sedation have exercised proper judgment and
discretion. Moreover, Mr. Meisel notes that adverse outcomes can result even
when a prudent and reasonable standard of care has been followed. Therefore,
the proposed regulation is not necessary.

RESPONSE: The Board disagrees with Mr. Meisel's assessment that the proposed
new rule is unnecessary. The Board notes that since the publication of the
original proposal in 1997, new oral agents have become available for use in the
provision of dental services and that given the potent nature of many of these
agents, regulation in this area of practice continues to be necessary to
protect members of the general public. Although the Board does not disagree
with the commenter's assessment that the majority of dentists utilizing
pharmacological agents to induce conscious sedation do so prudently and
appropriately, the fact remains that the use of such agents can be dangerous.
The Board continues to believe that patients will be better served by the
establishment of basic guidelines which must be followed by licensees in the
administration of such agents. The proposed new rule will help to ensure that a
reasonable standard of care is maintained, thereby decreasing the chances that
severe, adverse outcomes in the administration of pharmacological agents for
sedation purposes will occur.

COMMENT: Mr. Meisel observed that if the Board believes that regulation in the
area of conscious sedation with multiple pharmacologic agents is necessary, 14
hours of continuing education is more than adequate to protect the public and
no further regulation should be required. In addition, Dr. Clemente, on behalf
of the New Jersey Academy of General Dentistry, expressed support for the
continuing education requirements of the proposal, noting that continuing
education should be required of all dentists who utilize oral agents to induce
conscious sedation.

RESPONSE: The Board disagrees with Mr. Meisel's suggestion that continuing
education alone in the area of conscious sedation is sufficient to adequately
protect consumers. Given the ever evolving nature of pharmacological agents and
the risks their use can pose to patients, the Board believes that minimum
education and training, as well as minimum requirements concerning the
utilization of supportive personnel and office equipment are necessary to
ensure patient safety, and as such, is reproposing the rule at this time. The
Board notes in response to Dr. Clemente's comment that the new rule requires
the holder of an enteral sedation permit to complete a minimum of 20 hours of
continuing education.

COMMENT: Mr. Meisel objected to the permit requirement articulated in the
proposal, believing that the additional cost to licensed dentists, and the
administrative burden on the Board, is not warranted and that the subcommittee
of the Board which initially reviewed this issue determined that a permit
should not be required. In addition, Dr. Cheifetz believes that the permit
requirement will overburden dentists who are already licensed by the Board and
have both a CDC and an FDA permit. In addition, Dr. Clemente believes that
requiring a permit will increase the cost of care for patients by forcing
patients to obtain care in institutions or from permit holders who are multiple
agent dental specialists.

RESPONSE: The Board continues to believe that the permit requirement
articulated in the proposal is necessary to ensure compliance with the minimum
standards established in the new rule. The Board believes that the permit
requirement will help to ensure that only those licensees who are appropriately
trained will be administering pharmacological agents to achieve enteral
sedation of patients. In addition, the Board believes that any economic burden
to licensees, or administrative burden to the Board, will be outweighed by the
benefit to consumers in ensuring that only licensees who have satisfied the
minimum standards articulated in the rule are allowed to administer such
agents.

COMMENT: Dr. Cheifetz believes that the limitation in the proposal requiring
the pharmacological agents to be administered only in a treatment setting is
not in the best interests of patients. The commenter notes that often the
administration of oral premedicants are necessary to relieve patient anxiety
prior to entering the dental office. In addition, the commenter notes that the
proposal fails to take into account that, as licensed prescribers, dentists may
prescribe post-operative drugs in combinations which have the potential to fall
into the category of "conscious sedation with multiple oral agents." Therefore,
to require a permit for pre-operative or intra-operative multiple agents, but
not for post-operative medications, is inconsistent.

RESPONSE: The Board does not disagree with the commenter's assessment that
pre-and post-operative medications are sometimes necessary to relieve patient
anxiety prior to dental treatment. The Board notes, however, that the original
proposal, and the reproposal, contemplate the use of pre-and post-operative
medications because both proposals reference the administration and
prescription of pharmacological agents. Proposed N.J.A.C. 13:30-8.4(i) goes
further in that it encompasses not only the administration and prescription of
pharmacological agents to achieve enteral sedation, but the dispensing of such
agents as well. The Board notes that currently no rules exist to guide dentists
in their use of such medications, whether provided pre-operatively, intra-
operatively or post-operatively. The proposed new rule, therefore, will
establish standards and procedures which must be followed in order to ensure
that enteral sedation is properly administered, dispensed and prescribed.

COMMENT: Dr. Cheifetz requested clarification concerning whether individuals
exempt from the course work requirements of the conscious sedation permit would
also be exempt from the permit requirement. The commenter believes that
providers who already possess general anesthesia and intravenous sedation
administration permits should not be required to obtain an additional permit
for administration of oral medications.

RESPONSE: The Board agrees with the commenter's concern and notes that as part
of the reproposal, new N.J.A.C. 13:30-8.4(d) provides exemptions from the
enteral sedation permit requirement for the holders of general anesthesia and
parenteral conscious sedation permits.

COMMENT: Dr. Clemente observed that if the Board is concerned about treatment
of a specific patient population, such as children under the age of seven, the
Board should limit the application of the regulation to dentists who treat such
patients.

RESPONSE: The Board's concern in the use of pharmacological agents to achieve
the enteral sedation of the patient is not limited to a specific patient
population. The Board continues to believe that the age of the patient is
irrelevant and that the best way to protect the general public is through the
promulgation of a generally applicable rule.

The following is a summary of new rule N.J.A.C. 13:30-8.4, which the Board
is reproposing at this time, as well as new rule N.J.A.C. 13:30-8.1A, and
the proposed amendments to N.J.A.C. 13:30-5.1.

Proposed new N.J.A.C. 13:30-8.4(a) provides definitions for various terms
used throughout the new rule, including "enteral sedation with single or
multiple pharmacological agents." The Board notes that as provided in the
definition of "enteral sedation with single or multiple pharmacological
agents," the scope of the new rule has been expanded to include the
prescription or administration of one or more pharmacological agents, used for
the purpose of causing a depressed level of consciousness, but not a loss of
consciousness. Pharmacological agents include any non-parenteral agent, but do
not include any agent that is introduced by intravenous, intramuscular,
subcutaneous, submucosal or inhalation routes.

Proposed new N.J.A.C. 13:30-8.4(b) provides that a dentist shall not
administer, dispense or prescribe enteral sedation unless the minimum standards
of training and procedure established in the new rule are satisfied. Proposed
new N.J.A.C. 13:30-8.4(c) requires a dentist to obtain a permit, which shall
be renewed every two years, for each practice location in which enteral
sedation is administered, dispensed or prescribed. Proposed new N.J.A.C.
13:30-8.4(d), however, provides an exemption from the permit requirement in
subsection (c) for any dentist who holds a current general anesthesia (GA) or
parenteral conscious sedation (PCS) permit issued by the Board. Because
patients experience a more depressed level of consciousness under general
anesthesia or parenteral conscious sedation, the minimum training and standards
imposed by the Board for such permits are stricter than they would be under an
enteral sedation permit and, therefore, the Board is confident that the holders
of GA and PCS permits are already qualified to administer enteral sedation
without an additional permit.

Proposed new N.J.A.C. 13:30-8.4(e) provides that any dentist who wishes to
administer any pharmacological agent in any dose for the purpose of inhibiting
patient response beyond diminishing patient anxiety must possess an enteral
sedation permit. Proposed new N.J.A.C. 13:30-8.4(f) sets forth the
requirements that all applicants for an enteral sedation permit must satisfy. A
dentist applying for this new permit must submit a certification verifying that
the dentist has completed Board-approved post-doctoral course work at an
accredited dental school, or in a college or university clinical setting, which
has prepared the applicant to administer enteral sedation safely and
effectively. The course work must consist of a minimum of 40 hours of didactic
training in basic enteral sedation, physical evaluation, recognition and
management of complications and emergencies, and patient monitoring. The Board
has provided an exemption to this course work requirement in proposed new
N.J.A.C. 13:30-8.4(g) for any dentist who holds a GA or PCS permit or to any
dentist who has completed a general practice residency or has graduated from a
post-doctoral training program within three years of application. A dentist
completing a general practice residency or a post-doctoral training program
more than three years prior to application may also qualify for this exemption
if he or she has completed 20 hours of didactic training in enteral sedation
within the three years immediately preceding the date of application. The Board
believes that these exemptions from the course work requirement are warranted
because the training required of GA or PCS permit holders, and the training
obtained by dentists who have completed a general practice residency or post-
doctoral training program, is comprehensive and will adequately prepare such
persons to safely and effectively administer enteral sedation.

Proposed new N.J.A.C. 13:30-8.4(h) requires an applicant for an enteral
sedation permit to obtain emergency training by completing and maintaining
certification in a life support course. The applicant must furnish proof of
this training and certification to the Board upon biennial renewal of the
permit. Proposed new N.J.A.C. 13:30-8.4(i) permits a dentist to administer,
dispense or prescribe enteral sedation only in a dental treatment setting.
Subsection (i) also requires the dentist to provide for appropriate monitoring
of the patient during the administration of the sedation, to be prepared to
manage any reasonably foreseeable complications and to be in attendance in the
operatory until the patient's protective reflexes have returned and the patient
is determined by the dentist to be stable and ambulatory.

Proposed new N.J.A.C. 13:30-8.4(j) and (k) require the enteral sedation
permit holder to certify, upon permit renewal, that he or she employs a
licensed healthcare professional who is present in the office and is trained to
assist in the monitoring of the patient whenever enteral sedation is employed,
and that the dentist possesses basic equipment and supplies to deal with
emergency situations. At a minimum, a permit holder's office must contain
suction equipment capable of aspirating gastric contents from the mouth and
pharynx; a portable oxygen delivery system; a blood pressure cuff and
stethoscope; a pulse oximeter; an emergency drug kit; and back-up lighting,
suction and pulse oximeter by battery or generator power.

Prior to the administration of enteral sedation, proposed new N.J.A.C.
13:30-8.4(l) requires the permit holder to perform a physical evaluation of the
patient and take a complete medical history, which must include the patient's
previous medications, allergies and sensitivities. The patient history must be
maintained in the patient record for at least seven years. In addition,
subsection (l) requires that the patient record contain specific notations on
the use of enteral sedation, including the type of agent, dosage, duration of
the sedation, the patient's vital signs during the drug administration, and any
untoward reactions the patient may have suffered.

Proposed new N.J.A.C. 13:30-8.4(m) requires the holder of an enteral
sedation permit to complete at least 20 hours of continuing education in every
biennial period in physiology, pharmacology, patient evaluation, patient
monitoring, or medical emergencies. The 20 hours of training must be completed
consistent with the requirements imposed by the Board pursuant to its existing
continuing education rule for dentists set forth at N.J.A.C. 13:30-5.1. The
Board has determined that completion of the 20 hours of continuing education
required for the maintenance of an enteral sedation permit may be counted
toward satisfaction of the total number of credits required of a dentist
pursuant to N.J.A.C. 13:30-5.1, as is now the case with the credits earned
by dentists seeking to maintain GA or PCS permits, and, therefore, is proposing
that N.J.A.C. 13:30-5.1 be amended accordingly.

Proposed new N.J.A.C. 13:30-8.4(n) authorizes the board to inspect any
dental office in order to enforce the provisions of the new rule. Proposed new
N.J.A.C. 13:30-8.4(o) requires an enteral sedation permit holder, or an M.D.
or D.O. who is authorized to perform anesthesia services by the Board of
Medical Examiners, who administers enteral sedation at the office of another
dentist to remain present during the administration of the enteral sedation,
and to retain full responsibility for the procedure until the patient has fully
recovered and has been discharged. Proposed new N.J.A.C. 13:30-8.4(p)
requires an enteral sedation permit holder who administers enteral sedation at
the office of another dentist to ensure that minimum requirements for assisting
staff and equipment are satisfied. In addition, subsection (p) requires that
the mobile equipment and supplies of such permit holders be inspected once
every three years.

The Board is also proposing a new rule at N.J.A.C. 13:30-8.1A in order to
clarify who may administer deep sedation. The Board has defined "deep sedation"
in subsection (a) of N.J.A.C. 13:30-8.1A to mean the administration of
pharmacological and/or non-pharmacological agents, or a combination of the two,
to induce a state of depressed consciousness in a patient, which is accompanied
by a partial loss of protective reflexes, including the inability of the
patient to continually maintain an airway independently and/or to respond
purposefully to painful physical stimulation or verbal command. Subsection (a)
prohibits a dentist from administering, dispensing or prescribing any
pharmacological agent which will cause a patient to lapse into this type of
sedation unless the dentist possesses a GA permit issued by the Board pursuant
to N.J.A.C. 13:30-8.3. The Board believes that the risks associated with
this type of sedation are such that only those dentists who are properly
trained in the administration of general anesthesia and have satisfied the
requirements necessary to obtain a GA permit should be authorized to employ it
in their dental practices.

The Board believes that proposed new rule N.J.A.C. 13:30-8.1A is necessary
to ensure the health, safety and welfare of New Jersey consumers seeking dental
services from dentists practicing what has come to be known as "sleep
dentistry." The Board is aware that some dentists are currently advertising the
provision of "sleep dentistry" services as a way for very apprehensive patients
to undergo dental procedures. Patients are sedated and are placed in a very
"sleep-like" state prior to the start of the dental services and are
"awakened," or brought out of this sedated state, once the procedures are
complete. The Board believes that some dentists who advertise or offer "sleep
dentistry" services and are placing patients under deep sedation in order to
achieve the desired sleep-like state, are doing so without the benefit of a GA
permit. If a patient is going to be placed under deep sedation, which is
necessary if a "sleep-like" state is the desired effect, the Board believes
that the dentist must possess a GA permit in order to properly handle any
untoward reaction the patient may experience during the procedure. Subsection
(b) of proposed new rule N.J.A.C. 13:30-8.1A, therefore, provides that a
dentist who uses or advertises the terms "sleep," "sleep dentistry," or
"sleeplike-state," or any other similar words, in connection with the provision
of dental services will be considered to be inducing deep sedation. Such a
dentist must possess a GA permit.

The Board has determined that the comment period for this proposal shall be 60
days. Therefore, pursuant to N.J.A.C. 1:30-3.3(a)5, this proposal is
excepted from the rulemaking calendar requirement.

Social Impact

The Board believes that proposed new rule N.J.A.C. 13:30-8.1A will have a
positive impact upon dentists and the patients they serve. The proposed new
rule, which will require dentists who wish to engage in the practice of "sleep
dentistry," whereby a patient is placed under deep sedation, to possess a
general anesthesia permit, will ensure that dentists who administer this type
of sedation do so only after having satisfied the education, training and
equipment requirements applicable to GA permit holders. In addition, the
proposed new rule will clarify for dentists who do not posses GA permits that
they are prohibited from advertising or offering such services.

In addition, the Board believes that proposed new rule N.J.A.C. 13:30-8.4,
which establishes requirements for obtaining an enteral sedation permit, will
positively impact dentists and patients by establishing minimum education and
training requirements, as well as minimum requirements for equipment and
assistive staff which must be satisfied prior to administering, dispensing or
prescribing enteral sedation. Such requirements will help to ensure that only
those dentists who have been properly trained are authorized to offer enteral
sedation to patients.

The proposed amendment to N.J.A.C. 13:30-5.1 will not have any impact upon
dentists or the general public because the proposed amendment does not change
the number of continuing education credits that licensed dentists must obtain
in a biennial registration period. The proposed amendment provides only that
enteral sedation permit holders may count the 20 credits of continuing
education they must obtain under proposed new rule N.J.A.C. 13:30-8.4 toward
satisfaction of the existing continuing education requirements of N.J.A.C.
13:30-5.1.

Economic Impact

The Board believes that proposed new rule N.J.A.C. 13:30-8.1A may have an
economic impact upon licensed dentists who are currently offering "sleep
dentistry" services without GA permits. Such dentists will be economically
impacted by the new rule to the extent that they may incur costs associated
with satisfying the education, training and equipment requirements imposed by
the Board for the issuance of a GA permit pursuant to N.J.A.C. 13:30-8.3.
Dentists who choose not to obtain GA permits may be economically impacted by
the new rule to the extent that they may no longer advertise or provide such
services.

Proposed new rule N.J.A.C. 13:30-8.4 may have an economic impact upon
dentists who choose to administer enteral sedation in the provision of dental
services, to the extent that such dentists will be required to obtain a permit
issued by the Board and to satisfy the minimum education, training and
equipment requirements imposed by the new rule. In addition, the proposed new
rule will have an economic impact upon dentists who choose to obtain an enteral
sedation permit to the extent that permit holders will be required to complete
20 hours of continuing education in each biennial renewal period. The proposed
new rule may also have an economic impact upon a dentist who chooses to obtain
an enteral sedation permit to the extent that a permit holder who has multiple
offices will have to obtain an enteral sedation permit for each branch officer
or facility in which he or she administers enteral sedation.

The proposed amendment to N.J.A.C. 13:30-5.1, which provides that enteral
sedation permit holders may use the 20 hours of continuing education credit
they must obtain for this permit toward satisfaction of their biennial
continuing education requirements, will not have any economic impact upon
dentists because the proposed amendment does not alter the number of continuing
education credits dentists are currently required to obtain.

The Board believes that any economic impact that may be borne by dentists who
choose to obtain GA or enteral sedation permits as a result of the proposed new
rules will be outweighed by the benefit to patients in ensuring that deep
sedation and enteral sedation are administered only by permit holders who are
appropriately trained and properly equipped to administer such sedation.

Federal Standards Statement

A Federal standards analysis is not required because the proposed amendment
and new rules are governed by N.J.S.A. 45:6-1 et seq., and are not subject
to any Federal standards or requirements.

Jobs Impact

The Board does not believe that proposed new rules N.J.A.C. 13:30-8.1A and
8.4 and the proposed amendments to N.J.A.C. 13:30-5.1 will result in an
increase or decrease in the number of jobs in the State.

Agriculture Industry Impact

The Board does not believe that the proposed amendment and new rules will have
any impact on the agriculture industry in the State.

Regulatory Flexibility Analysis

The Regulatory Flexibility Act (the Act), N.J.S.A. 52:14B-16 et seq.,
requires the Board to provide a description of the types and an estimate of the
number of small businesses to which the proposed amendment and new rules will
apply. Currently, the Board licenses approximately 9,616 dentists. If these
Board licensees are considered "small businesses" within the meaning of the
Act, then the following analysis applies.

The Act requires the Board to set forth the reporting, recordkeeping and other
compliance requirements of the proposed amendment and new rules, including the
kinds of professional services likely to be needed to comply with the
requirements. The Act further requires the Board to estimate the initial and
annual compliance costs of the proposed amendment and new rules, to outline the
manner in which it has designed the proposed amendment and new rules to
minimize any adverse economic impact upon small businesses, and to set forth
whether the proposed amendment and new rules establishes differing compliance
requirements for small businesses.

The proposed amendment to N.J.A.C. 13:30-5.1 will not impose any reporting,
recordkeeping or compliance requirements upon dentists. Proposed new rules N.J.
A.C. 13:30-8.1A and 8.4 will not impose any reporting requirements upon
licensed dentists, but will impose recordkeeping and compliance requirements
upon such licensees. The recordkeeping and compliance requirements that will be
imposed upon dentists as a result of the proposed new rules are set forth in
the Summary above.

No additional professional services will be needed to comply with the proposed
amendment and new rules. The costs of compliance with the proposed amendment
and new rules are discussed in the Economic Impact above. The Board believes
that the proposed amendment and new rules should be uniformly applied to all
licensed dentists in order to ensure the health, safety and welfare of the
general public in the provision of dental services and, therefore, no differing
compliance requirements for any licensed dentists are provided based upon size.

Smart Growth Impact

The Board does not believe that the proposed amendment and new rules will have
any impact upon the achievement of smart growth or upon the implementation of
the State Development and Redevelopment Plan.

Full text of the proposal follows :

<< NJ ADC 13:30-5.1 >>

13:30-5.1 Continuing dental education requirements for dentists

(a)-(h) (No change.)

(i) Licensees who complete the required 20 hours of continuing education credit pursuant to the requirements for parenteral conscious sedation and/or general anesthesia permit holders as set forth in N.J.A.C. 13:30-8.2 and 8.3 shall be given credit for all 20 hours so completed. <<+Licensees who complete the required 20 hours of continuing education credit pursuant to the requirements for enteral sedation permit holders as set forth in N.J.A.C. 13:30-8.4 shall be given credit for all 20 hours so completed.+>>

(j)-(l) (No change.)

<< NJ ADC 13:30-8.1A >>

<<+13:30-8.1A Deep sedation; sleep dentistry+>>

<<+(a) No dentist shall administer, dispense or prescribe any pharmacological agent which shall cause a patient to lapse into deep sedation unless the dentist possesses a general anesthesia (GA) permit issued by the State Board of Dentistry pursuant to N.J.A.C. 13:30-8.3 and the dentist complies with all requirements set forth in N.J.A.C. 13:30-8.3. For purposes of this section, "deep sedation" means an induced state of depressed consciousness accompanied by partial loss of protective reflexes, including the inability to continually maintain an airway independently and/or to respond purposefully to physical stimulation or verbal command, which is produced by pharmacological or non-pharmacological agents or a combination thereof.+>>

<<+(b) A dentist who uses or advertises the terms "sleep," "sleep dentistry," "sleeplike-state," or any similar words or combinations thereof in connection with the provision of dental services shall be considered to be inducing deep sedation as defined in (a) above.+>>

<< NJ ADC 13:30-8.4 >>

13:30-8.4 <<-(Reserved)->> <<+Enteral sedation with single or multiple pharmacological agents+>>

<<+(a) For purposes of this section, the following words and terms shall have the following meanings, unless the context clearly indicates otherwise.+>>

<<+"Anxiolysis" means the diminution or elimination of anxiety.+>>

<<+"Enteral" means any method for the introduction of pharmacological agents, including oral, sublingual, rectal, nasal or any other method which relies upon absorption through the skin or any other mucous membrane.+>>

<<+"Enteral sedation with single or multiple pharmacological agents" means the administering, dispensing or prescribing of one or more pharmacological agents to be used concurrently for the purposes of causing a depressed level of consciousness and/or anxiolysis, but not a loss of consciousness. For purposes of this section, pharmacological agents shall include any non-parenteral agent, and shall exclude any agent introduced by intravenous, intramuscular, subcutaneous, submucosal, or inhalation routes, including nitrous oxide inhalation analgesia.+>>

<<+(b) No dentist shall administer, dispense or prescribe enteral sedation with single or multiple pharmacological agents (hereinafter "enteral sedation") unless the minimum standards of training and procedure set forth in this section are satisfied.+>>

<<+(c) No dentist shall administer, dispense or prescribe enteral sedation unless such dentist possesses an enteral sedation permit issued by the State Board of Dentistry, except as provided in (d) below, for a specified practice location which shall be renewed biennially. A dentist shall obtain a separate enteral sedation permit for each practice location at which enteral sedation is administered, dispensed or prescribed.+>>

<<+(d) A dentist who holds a current general anesthesia (GA) permit issued by the Board pursuant to N.J.A.C. 13:30-8.3, or a current parenteral conscious sedation (PCS) permit issued by the Board pursuant to N.J.A.C. 13:30-8.2, shall be authorized to use enteral sedation and shall not be required to apply for an enteral sedation permit pursuant to this section, provided the dentist complies with all requirements set forth in N.J.A.C. 13:30-8.3 or 8.2.+>>

<<+(e) No dentist may administer, dispense or prescribe any pharmacological agent in a dosage which has the potential to inhibit patient response beyond anxiolysis without the possession of an enteral sedation permit issued pursuant to this section.+>>

<<+(f) A dentist applying for a Board permit to administer, dispense or prescribe enteral sedation shall complete an application as provided by the Board. The dentist shall submit as part of a completed application, a certification verifying that the dentist has completed Board approved post-doctoral course work at an accredited dental school or in a college or university clinical setting sufficient to prepare a dentist to satisfactorily use enteral sedation safely and effectively. Such course work shall consist of a minimum of 40 hours of didactic training in basic enteral sedation, physical evaluation, recognition and management of complications and emergencies, and patient monitoring.+>>

<<+(g) A dentist applying for an enteral sedation permit shall be exempt from the course work requirements set forth in (f) above provided the applicant submits proof of having satisfied one of the following conditions:+>>

<<+1. The dentist holds a current general anesthesia (GA) permit issued by the Board pursuant to N.J.A.C. 13:30-8.3;+>>

<<+2. The dentist holds a current parenteral conscious sedation (PCS) permit issued by the Board pursuant to N.J.A.C. 13:30-8.2;+>>

<<+3. The dentist has completed an accredited general practice residency, or has graduated from a post-doctoral training program within the three years immediately preceding application. The general practice residency or the post-doctoral training program shall include a minimum of 60 hours of training in general anesthesia or conscious sedation; or+>>

<<+4. The dentist has completed an accredited general practice residency, or has graduated from a post-doctoral training program more than three years preceding application, and has completed a minimum of 20 hours of didactic training in basic enteral sedation, physical evaluation, recognition and management of complications and emergencies, and patient monitoring within the three years immediately preceding application. The general practice residency or the post-doctoral training program shall include a minimum of 60 hours of training in general anesthesia or conscious sedation.+>>

<<+(h) An applicant for an enteral sedation permit shall obtain emergency training by completing "Basic Life Support: Course C" of the American Heart Association or its equivalent or a course in Advanced Cardiac Life Support or its equivalent and shall maintain current certification in such course. The applicant shall furnish proof of this training and certification to the Board upon application for an enteral sedation permit and proof of recertification upon biennial renewal of the permit.+>>

<<+(i) A dentist may administer, dispense or prescribe enteral sedation only in a dental treatment setting and shall:+>>

<<+1. Provide for appropriate monitoring of the patient during the administration of the enteral sedation;+>>

<<+2. Be prepared to manage any reasonably foreseeable complications; and+>>

<<+3. Be in attendance immediately in the operatory until the patient's protective reflexes have returned and the patient is determined by the dentist to be stable and ambulatory.+>>

<<+(j) An applicant for an enteral sedation permit shall certify to the Board upon application for a permit and upon biennial renewal of the permit that the dentist employs a licensed health care professional who will be present in the office, trained to assist in the monitoring of the patient whenever enteral sedation is employed. The applicant shall further certify such health care professional is trained in, and capable of, monitoring vital signs and assisting in emergency procedures and that the health care professional maintains current certification in "Basic Life Support: Course C" or its equivalent or in Advanced Cardiac Life Support or its equivalent.+>>

<<+(k) An applicant for an enteral sedation permit shall certify as part of the application for a permit and upon biennial renewal of the permit that he or she possesses basic equipment and supplies to deal with emergency situations. The permit holder's facility shall contain the following readily accessible and properly operating equipment:+>>

<<+1. Suction equipment capable of aspirating gastric contents from the mouth and pharynx;+>>

<<+2. A portable oxygen delivery system including full face masks and a bag valve-mask combination with appropriate connectors capable of delivering positive pressure and oxygen-enriched patient ventilation;+>>

<<+3. A blood pressure cuff (sphygmomanometer) of appropriate size and a stethoscope or equivalent monitoring devices;+>>

<<+(l) Prior to the administration, dispensing or prescribing of enteral sedation, a physical evaluation of the patient shall be conducted by the permit holder and a complete medical history shall be obtained which shall include the patient's previous medications, allergies and sensitivities. The patient history shall be maintained in the patient's record for a period of not less than seven years. Specific notations on the use of enteral sedation shall be kept as part of every patient record and shall include the type of agent, the dosage, the duration of sedation, the patient's vital signs during administration, and any untoward reaction.+>>

<<+(m) A dentist who holds an enteral sedation permit shall certify to the Board upon biennial license renewal that the holder has completed at least 20 hours during the previous two-year period in continuing education courses, consistent with the requirements set forth in N.J.A.C. 13:30-5.1, in at least one of the following areas:+>>

<<+1. Physiology;+>>

<<+2. Pharmacology;+>>

<<+3. Patient evaluation;+>>

<<+4. Patient monitoring; and/or+>>

<<+5. Medical emergencies.+>>

<<+(n) Any designee of the Board shall be authorized during ordinary business hours to enter and inspect any dental office for the purpose of enforcing the provisions of this section.+>>

<<+(o) A dentist who utilizes the services of an enteral sedation permit holder or an M.D. or D.O. who is a member of the anesthesiology staff of an accredited hospital or who is authorized to perform anesthesia services by the Board of Medical Examiners pursuant to N.J.A.C. 13:35-4A shall not be deemed to be administering enteral sedation, provided that the enteral sedation permit holder, M.D. or D.O. remains present during the administration of the enteral sedation and bears full responsibility during the entire procedure until the patient has recovered fully and has been discharged.+>>

<<+(p) An enteral sedation permit holder invited by a dentist to provide enteral sedation services at a specific location shall bear full responsibility for compliance with all provisions of this section including the minimum requirements for assisting staff and equipment set forth in (j) and (k) above. When an enteral sedation permit holder utilizes mobile equipment and supplies to administer enteral sedation pursuant to this section, the mobile equipment and supplies of the permit holder shall be inspected by the Board or its designee not less than once every three years. "Mobile equipment and supplies," for purposes of this subsection, means any equipment and/or supplies which are transported and used by a permit holder to administer enteral sedation in one or more locations. When more than one permit holder utilizes the mobile equipment and supplies, it shall be the responsibility of the permit holder using the equipment and supplies to ensure that the mobile equipment and supplies satisfy the requirements of this section as set forth in (k) above prior to the administration of enteral sedation.+>>